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Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)

CompletedPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: HIV Infection

Interventions: DOR/ISL, ART

Countries: United States, Australia, Canada, Chile, Colombia, France, Italy, Japan

This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Is human immunodeficiency virus (HIV-1) positive
* Has been receiving continuous, stable oral 2-drug or 3-drug combination (± pharmacokinetic (PK) booster) with documented viral suppression (HIV-1 RNA \<50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.
* Females are eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive

Exclusion Criteria:

* Has HIV-2 infection
* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
* Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection
* Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
* Is currently taking long-acting cabotegravir-rilpivirine
* Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period
* Has a documented or known virologic resistance to doravirine (DOR)
* Expects to conceive or donate eggs at any time during the study

Locations (78)

Washington D.C., District of Columbia, United States
Ft. Pierce, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
West Palm Beach, Florida, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Kansas City, Missouri, United States
Hillsborough, New Jersey, United States
Chapel Hill, North Carolina, United States
Philadelphia, Pennsylvania, United States
Bellaire, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Sydney, New South Wales, Australia
Herston, Queensland, Australia
Carlton, Victoria, Australia
Murdoch, Western Australia, Australia
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Temuco, Araucania, Chile
Santiago, Santiago Metropolitan, Chile
Santiago, Santiago Metropolitan, Chile
Cali, Valle del Cauca Department, Colombia
+ 48 more on CT.gov